Job Application for Senior Director, Clinical Pharmacology at Formation Bio Back to jobs Senior Director, Clinical Pharmacology New York, NY; Boston, MA Apply About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position Formation Bio is seeking an experienced and innovative Senior Director of Clinical Pharmacology to join our Development team. In this role, you will lead our clinical pharmacology efforts, supporting late-stage drug development and contributing to business development activities. You will play a crucial role in advancing our mission to bring new treatments to patients faster and more efficiently through our innovative, tech-enabled drug development platform.
The role reports to the VP of Translational Medicine and you will be a key member of the Formation Bio Development team.
Responsibilities Develop clinical pharmacology strategy consistent with the target product profile, program goals and regulatory strategy In collaboration with the Clinical Development team, define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label Lead clinical pharmacology activities in supporting late-stage drug development programs across multiple therapeutic areas Design and oversee the execution of clinical pharmacology studies to support clinical development and regulatory submissions Determine scope, design, plan and analyze Phase 1-IV PK and PD studies, including development of appropriate population PK models. Contribute clinical pharmacology expertise to due diligence efforts for potential in-licensing opportunities Serve as the primary Clin Pharm lead and effectively participate in cross-functional teams to ensure integration of modern clinical pharmacology principles into project plan and study design integrated development strategies Provide scientific leadership in interactions with regulatory agencies and external partners Develop and implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology studies Manage resources, timelines, and budget for clinical pharmacology activities Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents About You PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role in conduct and/or oversight of clinical pharmacology Proven track record in leading clinical pharmacology efforts in late-stage drug development Strong understanding of regulatory
requirements for clinical pharmacology studies in support of clinical development Competent in the use of PK and PK/PD modeling software tools Experience in due diligence activities for in-licensing opportunities Excellent communication and leadership skills Ability to work effectively in a fast-paced, cross-functional environment Innovative mindset and enthusiasm for leveraging technology in drug development Total
Compensation Range: $311,000 - $388,500
Compensation Individual
compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive
benefits, and generous
perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 1-3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate . Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. Create a Job Alert Interested in building your career at Formation Bio? Get future opportunities sent straight to your email. Create alert Apply for this job * indicates a required field Autofill with MyGreenhouse First Name * Last Name * Email * Phone Country * Phone * Location (City) * Locate me Resume/CV * Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf Cover Letter Attach Attach Dropbox Google Drive Enter manually Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Are you legally authorized to work in the United States? * Select... Where are you most excited for AI to help your function? * What AI tools have you used, whether in your personal or work life? * Are you located in or willing to relocate to NYC, Boston, San Francisco, or Research Triangle Park? * Select... If hired by Formation Bio, will you now or in the future require sponsorship for employment visa status (e.g. H-1B, TN, OPT, etc)? * Select... Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Formation Bio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. Gender Select... Are you Hispanic/Latino? Select... Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to
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